Aptensio XR® (methylphenidate HCl extended-release) is a central nervous system
stimulant prescription medicine. It is used for the treatment of Attention Deficit
Hyperactivity Disorder (ADHD).

IMPORTANT SAFETY INFORMATION

Aptensio XR® is a federally controlled substance (CII) because it can be abused or
lead to
dependence. Keep
Aptensio XR® in a safe place to prevent misuse and abuse. Selling or giving away
Aptensio XR® may
harm others
and is against the law. Tell your physician if you, your child, or any family
members have
ever
abused or
been dependent on alcohol, prescription medicines, or street drugs.

Aptensio XR® should not be taken if you or your child are allergic to
methylphenidate
hydrochloride, or any of
the ingredients in Aptensio XR®, or are taking or have taken within the past 14 days an
antidepressant called
a monoamine oxidase inhibitor (MAOI).

Heart-related problems have been reported with methylphenidate hydrochloride and
other
stimulant
medications:

Psychiatric disorders have been reported with methylphenidate hydrochloride and
other
stimulant
medications:

All Patients

New or worse behavior and thought problems

New or worse bipolar illness

Children and Teenagers

New psychotic symptoms, such as hearing voices, believing things that are not
true, and
being overly
suspicious

New manic symptoms

Circulation problems in fingers and toes (peripheral vasculopathy, including
Raynaud’s
phenomenon) have been
reported with methylphenidate hydrochloride and other stimulant medicines:

Fingers or toes may feel numb, cool, or painful

Fingers or toes may change color from pale, to blue, to red

Tell your doctor if you have or your child has numbness, pain, skin color change,
or
sensitivity to temperature in the fingers or toes.

Call your physician right away if you or your child experience any heart-related
symptoms, such as chest pain, shortness of breath or fainting, new or worsening
mental (psychiatric) symptoms or new manic symptoms, or signs of unexplained
wounds appearing on fingers or toes while taking Aptensio XR®.

Aptensio XR® may not be right for you or your child. Before starting Aptensio XR®
tell your or
your
child’s
physicians about all health conditions (or a family history of) including:

If you are pregnant or plan to become pregnant. It is not known if Aptensio XR®
will harm
your unborn
baby. Talk to your doctor if you are pregnant or plan to become pregnant

If you are breastfeeding or plan to breast-feed. Aptensio XR® passes into your
breast milk.
You and your
doctor should decide if you will take Aptensio XR® or breast-feed

Possible serious side effects of Aptensio XR® are heart-related problems,
psychiatric
disorders,
circulation
problems in fingers and toes, and slowing of growth (height and weight) in children.
Children
should have
their height and weight checked often while taking Aptensio XR®. Aptensio XR® treatment
may be
stopped if a
problem is found during these checkups. Painful and prolonged erections (priapism)
have occurred
with
methylphenidate. If you or your child develop priapism, seek medical help right away.
Because of
the
potential for lasting
damage, priapism should be evaluated by a physician immediately.

Common side effects include:

Decreased appetite

Weight loss

Nausea

Stomach pain

Indigestion

Dry mouth

Vomiting

Trouble sleeping

Anxiety

Nervousness

Restlessness

Mood swings

Agitation

Irritability

Headache

Dizziness

Vertigo

Shaking (tremor)

Blurred vision

Increased blood pressure

Fast heart beat

Increased sweating

Fever

Talk to your physician if you or your child have side effects that are bothersome or do
not go
away.

This is not a complete list of possible side effects. Ask your physician or pharmacist
for more information.

Click
here for Full Prescribing Information, including Boxed Warning and Medication
Guide.

You are encouraged to report any negative side effects of prescription drugs to the
FDA. Visit www.fda.gov/medwatch, or call
1-800-FDA-1088.